Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT04441892
Status:
TERMINATED
Last Update Posted:
2023-07-25
First Post:
2020-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ackerman.michael@mayo.edu', 'phone': '507-284-8900', 'title': 'Dr. Michael J. Ackerman', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Last patient enrolled in February of 2020. Enrollment was paused because of stay-at-home COVID mandates and even when general clinical operations resumed, elective clinical studies like these were not immediately resumed in the ECG monitoring lab to limit the number of people around patients. By the time recruitment could resume, the collaborating company had run out of funding for the study and the study was terminated. Study only enrolled 33 participates out of anticipated 1050.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'QTc Meter', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'QTc Meter - Healthy Controls', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Low Cost QTc Meter for Long QT Syndrome Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QTc Meter', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}, {'id': 'OG001', 'title': 'QTc Meter - Healthy Controls', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QTc Meter', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}, {'id': 'FG001', 'title': 'QTc Meter - Healthy Controls', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QTc Meter', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}, {'id': 'BG001', 'title': 'QTc Meter - Healthy Controls', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.\n\nQTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-07-24', 'size': 1369276, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-20T12:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'COVID, lack of funding and interruption of patient recruitment led to ending the study early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2020-06-17', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-06', 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low Cost QTc Meter for Long QT Syndrome Screening', 'timeFrame': 'Baseline', 'description': 'Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Long QT Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the primary care environment.', 'detailedDescription': "The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda SL ECG Lab (or Baldwin Building)and enrolled during their appointment for a clinically indicated 12-lead ECG. A second arm of Phase II of this study will include approaching 50 healthy subjects at the Baldwin Building to seek interest in participation which will consist of (1) 30 second device recording to help further calibrate and test the device for optimal enhancement. These 50 subjects will not be required to have a clinical or research 12-lead ECG as the investigators will be simply testing the efficiency and accuracy of the device. LQTS will be studied in order to assess the ability of the LQTS screener to accurately detect a patient with established QT prolongation in the context of distinct and varied T wave morphologies The advanced prototype will be placed in the same manner as the device used in Phase I of the study by being lightly placed on the child as pictured below. Similarly, the investigators will use ultrasound gel to obtain a better reading, if applicable. Once completed, a photograph of the torso of the child will be taken from the same views as before (one aerial view and one side view) with neither the head nor the face in the picture. Coded ECG-tracings will be transmitted to the app and shared with Blue Ox Health Corporation and Minnesota Health Solutions as done previously in phase I. Additionally, coded tracings and data from the 12-lead ECG will be shared with Blue Ox Health Corporation and Minnesota Health Solutions to aid in comparison to device tracings and optimization of the algorithm. The 12-lead ECG will be obtained from the subject's medical record and coded before being shared with collaborators. Study coordinators will also review the patient's medical record to determine whether the participants have been diagnosed with a genetic disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants (Day 0 - 5 years).\n* Long QT Syndrome(LQTS).\n* Newborns without LQTS (Controls).\n* Parental willingness to provide informed consent and follow the study protocol.\n\nExclusion Criteria:\n\n* Children \\> 5 years old.\n* Those with genetically elusive LQTS.\n* Infants with congenital heart disease.\n* Infants born \\< 32 weeks EGA.\n* Patients with a cardiac device implant (pacemaker/ICD).'}, 'identificationModule': {'nctId': 'NCT04441892', 'briefTitle': 'Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care', 'orgStudyIdInfo': {'id': '18-006014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QTc Meter', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device', 'interventionNames': ['Device: QTc Meter']}, {'type': 'EXPERIMENTAL', 'label': 'QTc Meter - Healthy Controls', 'description': 'Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.', 'interventionNames': ['Device: QTc Meter']}], 'interventions': [{'name': 'QTc Meter', 'type': 'DEVICE', 'description': 'Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.', 'armGroupLabels': ['QTc Meter', 'QTc Meter - Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Ackerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Ox Healthcare Partners', 'class': 'INDUSTRY'}, {'name': 'Minnesota Health Solutions', 'class': 'INDUSTRY'}, {'name': 'iCardiac Technologies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael J. Ackerman', 'investigatorAffiliation': 'Mayo Clinic'}}}}